1. Field of the Invention
The present invention relates to automated non-invasive patient monitoring devices. Specifically, it relates to non-invasive patient monitoring devices which incorporate integrated actigraphy as a means for synchronizing physiological measurements with activity/rest cycles.
2. Description of the Related Art
Automated non-invasive patient monitoring devices such as the devices used in ambulatory blood pressure monitoring are well-known and commercially available. These devices enable clinicians to monitor a patient's physiological data during regular daily activity in the patient's everyday environment.
The human circadian or diurnal rhythm, including day-night patterns of vital signs, has a fundamental role in both in the proper diagnosis and treatment of patients. For example, almost all cardiovascular system functions, including heart rate, blood pressure, and blood flow exhibit circadian variability. Such rhythms in the physiological status of the cardiovascular system along with temporal patterns in the occurrence and intensity of environmental triggers of disease give rise to predictable-in-time differences in the susceptibility/resistance of persons to serious cardiovascular events such as heart attacks and strokes. As such, it is extremely valuable to have physiological data obtained on a patient correlated to their exact circadian rhythm including day-night patterns.
Existing physiological data monitors, whether home or clinic patient monitors as well as ambulatory patient monitors (see U.S. Pat. Nos. 4,830,018, 4,706,684, 6,251,080, 4,576,180, 4,967,756, 4,889,132), do not directly monitor and factor in the circadian or diurnal rhythm of a patient or include an integrated actigrapher. As such, they miss a critical component of the patient's conditions that would aid in better assessing the patient and developing a course of therapy optimized for that patient's conditions. Further, a comparison of two or more extended term (e.g., 24 hour) diagnostic data sets for a patient—such as that of a pre- and post-medication treatment—often fails to take into account subtle differences in the patient's circadian or diurnal rhythm. Any consideration for circadian rhythm variability is typically dependent on incomplete or imprecise statements or diaries from healthcare providers or patients which can drastically skew the results of any analysis or comparison.
Integrated actigraphy is critical to determine the patient's activity/rest patterns and to make possible automatic synchronization of pre-treatment and post-treatment recordings in order to evaluate the efficacy of treatment such as antihypertensive therapy. Integrated actigraphy is also critical in order to synchronize physiological recordings from different patients enrolled in clinical studies and clinical trials since each individual has different activity/rest patterns (for instance, patients wake up a different times).
Actigraphy has been recognized in prior art to identify circadian rhythms, sleep patterns, pharmacological treatment of hypertension, resynchronization of body clocks, etc. However, such prior art does not include the collection of physiological data over an extended basis in conjunction with actigraphy. As such, this prior art does not provide the ability to combine extended monitoring of physiological data along with actigraphy which are critical to correlating and analyzing patient conditions in response to circadian rhythm variations including asleep/awake patterns.